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FDA leader urges team approach to pharma manufacturing processes

Dr. Moheb Nasr’s candid keynote address is one of many highlights at CleanRooms CCT 2005

BY STEVE SMITH

BOSTON, MA-“Your job is to assure us your process is safe; our job is not to tell you how to manufacture drugs.”

With that candid exhortation to pharmaceutical developers, Dr. Moheb Nasr, director of the FDA’s Office of New Drug Chemistry, concluded a keynote address that was among several highlights to the CleanRooms Contamination Control Technology 2005 conference and exhibition, held at the World Trace Center in Boston, Mass., in mid-March.

Thomas Finneran, newly-appointed president of the Massachusetts Biotechnology Council, kicked off the CCT networking reception and mingled with exhibitors and attendees.

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In his presentation on risk-based pharmaceutical assessment, Dr. Nasr said the FDA has heard the industry and is seeking to eliminate a perception that the agency’s policies often hinder new product development. “We were told repeatedly that because of us, people are reluctant to introduce new technology or encourage new technology advances,” acknowledged Dr. Nasr. But he says the FDA is responding by aiming for risk-based assessments of pharmaceuticals rooted in science-based policies and standards. “If you make your decisions based on science, you can’t go wrong,” he explained.

Dr. Nasr advocates a team approach in assessing pharmaceutical manufacturing processes, with a new focus on integrating the review and inspection functions. The agency’s risk-based approach focuses on critical quality attributes and their relevance to safety and efficacy (chemistry, formulations, stability, manufacturing processes, etc.). While Dr. Nasr notes there is “no such thing as zero-based risk to the public, our job is to weigh risk versus the benefit” to help manufacturers facilitate a drug coming to market.

Contamination-control professionals from a variety of industries attended the two days of workshops on critical manufacturing process issues.

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While the agency seeks to make the approval process easier and more efficient for drug developers, the FDA is also asking for cooperation from the industry. Dr. Nasr confided that the Agency is “supposed to spend most of our time in assessing the manufacturing process, but a lack of personnel with relevant expertise” has contributed to a logjam in the drug approval process. Accordingly, he encouraged drug developers to think quality rather than quantity when filing for FDA approval, and “not dump a file drawer of info at us. That takes too long. It’s not how much you give us, but what you give us” that will speed the process, Dr. Nasr said.

From semi to pharma

Contamination-control professionals from a variety of industries attended the two days of workshops on critical manufacturing process issues, presented in six tracks ranging from basic technology and production applications to environment management and nanotechnology. Attendees also networked with industry representatives on the exhibit hall floor where they received demos of the latest contamination-control technologies and products.

Other highlights included a keynote presentation on the unique contamination-control design requirements for the National Institute of Standards and Technology (NIST) Advanced Measurement Laboratory in Gaithersburg, Md., a visit from Thomas Finneran-newly-appointed president of the Massachusetts Biotechnology Council, and a cleanroom fashion show featuring the latest in garments and contamination-control apparel.

Dr. Moheb Nasr, director of the FDA??s Office of New Drug Chemistry, presented a candid and informative keynote address at the Contamination Control Technology conference and exhibition in Boston.

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“The overwhelming majority of people said they had a great experience,” says CleanRooms Chief Editor, John Haystead. “In particular, attendees commented favorably on the scope and quality of the technical program and the guest speakers. The events and presentations on the exhibit floor were also popular, particularly the cleanroom fashion show.”

The CleanRooms Contamination Control Technology 2006 conference is scheduled for March 15-16 at the Hynes Convention Center in Boston. For more information, visit: www.cleanrooms.comIII

Best of Show winners

Attendees voted the following as Best of Show category winners at this year’s CleanRooms Contamination Control Technology conference and exhibition in Boston: